About the Job

The Director, Compliance Officer is a member of the Legal and Compliance Department and is responsible for partnering with the business to implement the Business Ethics and Compliance Program within specific units. The Compliance Officer serves as the main compliance point of contact for those business units and is a key partner of the business leaders in helping identify and mitigate compliance risks and drive key compliance policy and initiatives. 

Key Responsibilities

• Identify compliance-related gaps in current processes or practices and develop corresponding mitigation plans, especially with respect to healthcare compliance.
• Mitigate risk by reinforcing established procedures, spotting and escalating issues to Compliance leadership, and modeling business integrity and ethical behavior.
• Work closely with the Chief Compliance Officer and Compliance leadership to shape the Business Ethics and Compliance Program.
• Partner with designated business functions across FMI (e.g. Sales, Medical Affairs, etc.) on corporate compliance concerns related to business processes.
• Provide support to FMI functional teams to ensure training is aligned with compliance priorities and dedicates sufficient focus to cover important compliance topics.
• Within the assigned business functions, develop and maintain policies and procedures for the general operation of the Business Ethics and Compliance Program and its related activities and manage day-to-day operation of the Business Ethics and Compliance Program.
• Collaborate with Compliance Training & Communications to develop and deliver training to ensure that FMI employees are properly trained on compliance resources, risk areas, policies and procedures and reporting duties.
• Assist Compliance Monitoring with investigations, audit, and other monitoring activities to assess and detect risk areas and potential areas of concern within the Business Ethics and Compliance Program.
• Prepare and present updates to the Compliance Committee and FMI’s Senior Management Team. Keep the Compliance Committee and the Senior Management Team generally informed of the operation and progress of the Business Ethics and Compliance Program.
• Keep apprised of compliance trends in life sciences industry and incorporate improvements as applicable for FMI.
• Lead or support other critical initiatives as required.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Master’s Degree or other advanced degree such as a Juris Doctor degree
• 10+ years of progressively responsible experience in a compliance role, including 2+ years of healthcare compliance experience in the life sciences industry.

Preferred Qualifications

• Certification in compliance, such as CHC, CCEP, CIPP, CCP, CHPC, or the Seton Hall Law School Compliance Program
• 2+ years of experience:
  • within healthcare compliance in the life sciences industry, focused in the diagnostics sector or alternatively in the device or therapeutics sectors
  • working within a broad based, comprehensive compliance program, with demonstrated success in developing and implementing a program
  • working in a large law firm specializing in healthcare matters and healthcare compliance
  • with learning management systems
  • delivering and developing training related to compliance
• Strong understanding of policies and procedures related to healthcare compliance issues, including anti-kickback, privacy, e.g. HIPAA and GDPR, False Claims Act, and Stark Law
• Advanced Microsoft Word, Excel, and PowerPoint skills
• Strong professional and interpersonal skills and a demonstrated ability to work effectively and congenially with employees at diverse levels

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